MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CRBM SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 8892382

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros carbamazepine (crbm) results were obtained from non-vitros mas omnicore quality control fluids using vitros chemistry products crbm slides lot 3905-0114-4783 on a vitros 5600 integrated system.A definitive assignable cause of the lower than expected results could not be determined.Based on historical quality control results a vitros crbm reagent performance issue could not be ruled out as a contributing factor of the event.However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crbm reagent lot 3905-0114-4783.Vitros crbm marker precision testing was not performed on the vitros 5600 integrated system at the time of this report.An instrument issue was not able to be ruled out as a contributor of the event.An issue related to the mas qc fluids could not be confirmed nor ruled out as a contributing factor of the event.Acceptable vitros crbm qc results were obtained when the customer used an alternate lot of the mas qc fluids.Email address for contact office above is (b)(6).

Event Description

The investigation has determined that lower than expected vitros carbamazepine (crbm) results were obtained from non-vitros mas omnicore quality control fluids using vitros chemistry products crbm slides lot 3905-0114-4783 on a vitros 5600 integrated system.Mas omnicore lot ocr2210 l3 results of 10.6904, 6.7035, 7.0288, 10.6643, 10.1034 and 10.0279 ug/ml vs an expected result of 15.76 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros crbm results were from a quality control fluid and were not reported from the laboratory.It could not be concluded that patient sample results were not affected.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number three of six mdr¿s for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and ivd (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CRBM SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 14841947
• MDR Text Key: 303057783
• Report Number: 1319809-2022-00035
• Device Sequence Number: 1
• Product Code: KLT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 8892382
• Device Lot Number: 3905-0114-4783
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1